Abstract
Cannabidiol (CBD) is 1 of > 100 cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis). Despite its complex and rapidly evolving regulatory status in the United States, projected retail sales of CBD products—hemp, cannabis and pharmaceutical—are as high as $1.9 billion by 2020. CBD products can currently be purchased online, over the counter, and at cannabis-specific dispensaries throughout most parts of the country, despite the fact that CBD is presently deemed a Schedule I controlled substance by the U.S. Drug Enforcement Administration and renounced as a dietary supplement ingredient by the U.S. Food and Drug Administration (FDA). These products are largely unregulated, and are being used predominantly to treat specific medical conditions. Recent FDA approval of Epidiolex (CBD) as a treatment for certain pediatric seizure disorders will prompt scheduling of CBD and likely alter FDA enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), which to date has mostly been in the form of warning letters. Persuasive legal arguments contend that CBD's legal status is based on its source. According to these arguments, there are three legal sources. CBD-derived from: (1) parts of the Cannabis plant that do not meet the definition of cannabis in the Controlled Substances Act (CSA); (2) imported “non-psychoactive hemp”; and (3) “Industrial hemp” cultivated as part of a state pilot program per the 2014 Farm Act. Although CBD's lawful status with respect to the CSA appears to be expanding, its future regulatory status with respect to the FD&C Act is difficult to predict.
Highlights
Cannabidiol (CBD) is 1 of > 100 cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis)
CBD is 1 of >100 cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis), a plant more well-known colloquially as marijuana or hemp, referred to as ‘‘cannabis.’’2 CBD was first isolated in 1940 and characterized structurally in 1963.3,4 With projected retail sales of CBD products—hemp, cannabis and pharmaceutical—as high as $1.9 billion by 2020, 1The Center for Medical Cannabis Education, Del Mar, California. 2Helfgott Research Institute, National University of Natural Medicine (NUNM), Portland, Oregon. 3Kight Law Office LLC dba Kight On Cannabis, Asheville, North Carolina
The difference between cannabis and hemp is the chemical composition, as it relates to the concentration of delta-9 tetrahydrocannabinol (THC), the primary intoxicating compound found in Cannabis
Summary
The current legal and regulatory status of CBD is both complex and evolving, with regard to its legal status vis-a-vis the CSA and its regulatory status under the FD&C Act. Myriad factors contribute to this complexity, including convoluted and conflicting regulations at both the federal and state levels, court rulings that have failed to achieve resolution, confusion relating to the definitions of cannabis and hemp, pending legislation, and the FDA’s position on CBD as a drug and not a dietary supplement ingredient. Individuals are currently using CBD products to treat medical conditions without the support of informed healthcare providers.[37]. The approval of Epidiolex will precipitate scheduling of CBD, it is less clear how it will influence the FDA’s enforcement priorities relating to hemp-derived CBD products. Rod Kight, Esq. is an attorney and principal of Kight Law Office, LLC dba Kight on Cannabis, a law firm that represents businesses in the cannabis industry
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